Transcription of Sample Size Calculations - bebac.at
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Sample Size Calculations - bebac.at
1 57 Sample Sample Size CalculationsSize CalculationsIn vitro in vivoIn vitro in vivoCorrelation (IVIVC), Biowaivers & Statistical Aspects of BioequCorrelation (IVIVC), Biowaivers & Statistical Aspects of Bioequivalenceivalencein Drug Product Developmentin Drug Product Development| | MumbaiMumbai, , 27 27 January January 20122012 Pharma EdgeHelmut Sch tzBEBACH elmut Sch tzBEBACW ikimediaWikimediaCommons Commons 2007 2007 Sujit KumarSujit Kumar Creative Commons AttributionCreative Commons UnportedUnportedSample Size CalculationsSample Sample Size CalculationsSize CalculationsNamaste!Namaste!2 57 Sample Sample Size CalculationsSize CalculationsIn vitro in vivoIn vitro in vivoCorrelation (IVIVC), Biowaivers & Statistical Aspects of BioequCorrelation (IVIVC), Biowaivers & Statistical Aspects of Bioequivalenceivalencein Drug Product Developmentin Drug Product Development| | MumbaiMumbai, , 27 27 January January 20122012 Pharma EdgeOverviewOverview Classical Sample size estimation in BE Patient s & producer s risk Power in study planning Uncertainties Variability Test/Reference-ratio Sensitivity analysis Recent developments Review of guidelines3 57 Sample Sample Size CalculationsSize CalculationsIn vitro in vivoIn vitro in vivoCorrelation (IVIVC), Biowaivers & Sta
2 • 57 Sample Size Calculations In vitro in vivo Correlation (IVIVC), Biowaivers & Statistical Aspects of Bioequ ivalence in Drug Product Development | …
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